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FDA Says Medtronic Took 2 Years to Recall Defective Pumps
July 10th, 2009 | 
Author: July 11, 2009
The Wall Street Journal
by Jon Kamp
Medtronic Recalls Insulin Devices
The following is an excerpt from one of many articles relating to the recent Medtronic infusion set recall of approximately 3 million sets.
Late last month, the medical-device maker came under fire from the U.S. Food and Drug Administration, which warned Medtronic about what the agency called a failure to properly report and remedy flaws in the Synchromed drug pump and the MiniMed insulin pump.
In a letter, the FDA said it took Medtronic almost two years to recall Synchromed II pumps after discovering a missing propellant in some versions. The agency also said the company didn’t follow proper reporting procedures involving complaints about the insulin pump.
Posted in FDA Alerts, Recalls, Product Safety | Tags: insulin pumps, medtronic, recalls | 
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